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Table 5 Evidence table for accepted randomized controlled trials on multimodal care and lateral epicondylitis

From: Multimodal care for the management of musculoskeletal disorders of the elbow, forearm, wrist and hand: a systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration

Author(s), Year Subjects and Setting; Number (n) Enrolled Interventions; Number (n) of Subjects Comparisons; Number (n) of Subjects Follow-up Outcomes Key Findings
Bisset et al., 2006, 2009 [62, 63] Participants (18–65 y.o.) from Brisbane, Australia.
Case definition: lateral elbow pain increased with palpation of the lateral epicondyle, gripping, resisted wrist or second or third finger extension of >6 weeks duration.
(n = 198)
Multimodal care by a PT (8 visits/6 weeks): elbow manipulation, exercise (supervised and home-based), self-manipulation, educational booklet (disease process, self management advice, ergonomics).
(n = 66)
Corticosteroid injection by a GP (1 ml 1 % lidocaine with 10 mg triamcinolone acetonide in 1 ml); 1 injection at painful points and second injection after two weeks if necessary; advice to return gradually to normal activities; educational booklet (disease process, self management advice, ergonomics) (n = 65)
Reassurance and Advice: reassurance (ADL modifications, analgesic drugs, heat, cold, braces), educational booklet (disease process, self management advice, ergonomics) (n = 67)
6, 12, 26 and 52 weeks Primary Outcome: Global improvement (6 point Likert Scale); success = “completely recovered” or “much improved”; recurrence (“successful” to “unsuccessful”); pain-free grip force (digital grip dynamometer, affected side/unaffected side x 100)
Secondary Outcome: pain severity (VAS 0–100 mm); elbow disability (Pain Free Function Questionnaire (PFFQ)); Sensorimotor function: SRT(ms); RT1(ms); RT2(ms); S1(cm/s); S2(cm/s)
Adverse events.
Relative Risk (Multimodal Care vs. Corticosteroid Injection):a
Success
6 weeks: RR 0.79 (95 % CI 0.63; 0.99)
12 weeks: RR 1.53 (95 % CI 1.11; 2.10)
26 weeks: RR 1.73 (95 % CI 1.28; 2.34)
52 weeks: RR 1.32 (95 % CI 1.09; 1.59)
Recurrence
After 6 weeks: RR 0.11 (95 % CI 0.05; 0.25)
Difference in Mean Change from Baseline: 
(Multimodal Care - Corticosteroid Injectionb)
Pain-free Grip Force
6 weeks:--17.4 (99 % CI -22.4; -12.4)
12 weeks: 13.1 (99 % CI 7.6; 18.6)
26 weeks: 28.2 (99 % CI 21.6; 34.8)
52 weeks: 12.3 (99 % CI 6.7; 17.9)
Pain Severity
6 weeks: -13.4 (99 % CI -18.8; -8.0)
12 weeks: 19.4 (99 % CI 13.6; 25.2)
26 weeks: 20.0 (99 % CI 14.6; 25.4)
52 weeks: 18.2 (99 % CI 12.6; 23.8)
PFFQ
6 weeks: -20.3 (99 % CI -26.9; -13.6)
12 weeks: 12.4 (99 % CI 5.1; 19.7)
26 weeks: 21.4 (99 % CI 15.1; 27.6)
52 weeks: 18.8 (99 % CI 11.9; 25.7)
Sensorimotor Function
There were no clinical or statistical differences between groups in SRT, RT1, RT2, S1 or S2 at any follow-up point.
Relative Risk Reduction (Multimodal Care vs. Reassurance and Advice):a
Success
6 weeks: RR 2.60 (99 % CI 1.63; 4.15)
12 weeks: RR 1.31 (99 % CI 0.98; 1.73)
26 weeks: RR 1.08 (99 % CI 0.88; 1.32)
52 weeks: RR 1.07 (99 % CI 0.93; 1.22)
Recurrence
6 weeks: RR 0.85 (95 % CI 0.27; 2.65)
Difference in Mean Change from Baseline 
(Multimodal care – Reassurance and Adviceb):
Pain-free Grip Force
6 weeks: 24.0 (99 % CI 19.0; 29.0)
12 weeks: 14.3 (99 % CI 9.5; 19.1)
26 weeks: 15.4 (99 % CI 9.9; 20.9)
52 weeks: 10.0 (99 % CI 4.4; 15.6)
Pain Severity
6 weeks: 12.2 (99 % CI 7.3; 17.1)
12 weeks: 5.8 (99 % CI 0.8; 10.8)
26 weeks: 4.9 (99 % CI -0.5; 10.3)
52 weeks 1.4 (99 % CI -4.2; 7.0)
PFFQ
6 weeks: 15.7 (99 % CI 9.9; 21.5)
12 weeks: 17.4 (99 % CI 11.2; 23.6)
26 weeks: 5.0 (99 % CI -1.1; 11.1)
52 weeks: 10.4 (99 % CI 4.1; 16.7)
Sensorimotor Function
There were no clinical or statistical differences between groups in SRT, RT1, RT2, S1 or S2 at any follow-up point.
Adverse Events
Minor: pain following treatment, loss of skin pigment; subcutaneous tissue atrophy. 
Multimodal Care: 10.6 %; Corticosteroid Injection: 20.0 %; Wait and See: 0.0 %.
Haahr et al., 2003 [64] Adults (18–66 y.o.) with lateral epicondylitis consulting with GP in Ringkjoebing County, Denmark.
Case definition: new episode (<1 year) of lateral epicondylitis (i.e., indirect tenderness at or within 2 cm from lateral humeral epicondyle on resisted extension of wrist and/or third finger (n = 289).
Multimodal Intervention by GP and ergonomist: reassurance and advice (against complete rest, stay active, avoid aggravating activities, adjust work conditions) by GP. Graded exercises by ergonomist. OTC analgesics, (n = 148) Usual care provided by GP. (n = 141) 1 year Primary Outcome:
Self-reported overall development of condition (5 point Likert; ‘much better’ to ‘much worse’); 50 % reduction in combined pain and function score
Secondary Outcome: sickness absence, ceased or changed job, start education or rehabilitation activity, labour compensation claim.
Perceived unchanged or worse overall developmentc:
Control: OR 1.0
Multimodal Care: OR 1.0 (95 % CI 0.4; 2.3)
Nagrale et al., 2009 [65] Outpatient clinic, Wardha, Maharashtra, India (30–60 y.o.).
Case definition: tenderness to palpation over the lateral humeral epicondyle, pain with gripping, passive wrist flexion with elbow extension and resisted wrist extension lasting ≥1 month (n = 60)
Cyriax physiotherapy (deep transverse friction massage plus Mill’s manipulation), education (ergonomics, activity modification) (3/week; 4 weeks).
(n = 30)
Phonophoresis (5 min) over lateral epicondyle (Voveran Emulgel frequency 1 MHz, 0.8 W/cm2 intensity), supervised exercise, education (ergonomics, activity modification) (3/week; 4 weeks)
(n = 30)
4 and 8 weeks Primary Outcome: pain severity (VAS 0–10 cm); pain-free grip strength (dynamometer, pounds); Tennis Elbow Function Scale (TEFS) (0–40) Cyriax Physiotherapy – Phonophoresis + Exercise
Difference in Mean Change Score a,d
Pain severity
4 weeks: 1.8
8 weeks: 2.5
Pain-free Grip Strength
4 weeks: 12.4
8 weeks: 14.5
TEFS
4 weeks: 7.7
8 weeks: 8.9
Smidt et al., 2002 [66] Primary care setting (85 family doctors), referred to 5 research centres, Netherlands (18–70 y.o.).
Case definition: lateral epicondylitis ≥6 weeks duration (n = 185)
Multimodal Care: provided by a PT (9visits/6 weeks): pulsed ultrasound, massage, exercise; home exercise equipment and instruction booklet.(n = 64) Corticosteroid Injection (1 mL of 10 mg/mL triamcinolone cetonide + 1 mL 2 % lignocaine) at each tender spot; maximum 3 injections in 6 weeks, avoid pain-provoking activities provided by family doctor
(n = 62)
Reassurance and Advice: 1 visit with family doctor in 6 weeks. Advice (pain provoking activities, ergonomic), paracetamol or NSAIDs if necessary, await spontaneous improvement (n = 59)
6, 12, 26 and 52 weeks Primary Outcome: Global improvement (“completely recovered“to “much worse”); success = “completely recovered” or “much improved”; severity of main complaint (NRS 0–10); pain during day (NRS 0–10); inconvenience (NRS 0–10); functional disability (modified pain-free function questionnaire, 0–40); PT rated overall severity (0–10). 
Secondary Outcomes: pain-free grip strength (kg); maximum grip strength (kg); pressure pain threshold; satisfaction with intervention.
All scales transformed to 0–100.
Adverse events.
Multimodal Care – Reassurance and Advice
Difference in Mean Change Score a
Success rate
6 weeks:
RR 1.46 (95 % CI 0.93; 2.29)
52 weeks:
RR 1.09 (95 % CI 0.95; 1.25)
Multimodal Care - Corticosteroid injection
Success rate
6 weeks: RR 0.51 (95 % CI 0.39; 0.67)
52 weeks: RR 1.31 (95 % CI 1.09; 1.57)
Adverse events: increased pain; radiating pain; facial flush; skin irritation; red swollen elbow; skin colour change; other minor or temporary adverse reactions.
Multimodal: 64 %; Corticosteroid Injection:58 %; Reassurance and Advice: 17 %
Struijs et al., 2004 [73] Patients referred from GP and primary care PT to outpatient clinic, the Netherlands.
Case definition: pain aggravated by pressure on lateral epicondyle and resisted wrist dorsiflexion (≥6 weeks duration)
(n = 180)
Multimodal Care by PT (9 visits/6 weeks): pulsed ultrasound, friction massage, strengthening and stretching exercise, home exercise with diary.
(n = 56)
Brace: provided by PT (1 visit): Epipoint elbow brace worn over common extensor tendon.
(n = 68)
Combination Group: Multimodal Care plus Brace intervention.
(n = 56)
6, 26 and 52 weeks Primary Outcome: Global improvement (6 point Likert Scale) (“completely recovered“to “much worse”); success = “completely recovered” or “much improved”; severity of complaints (0–11 NRS); pain intensity of most severe complaint (0–11 NRS); modified PFFQ (10 item, 0–4)
Secondary Outcome: Inconvenience during daily activities (0–10); pain-free grip strength (kg); maximum grip strength (kg); pressure pain threshold at lateral epicondyle (kg/cm2); satisfaction with treatment (0–10). All outcomes transformed to 100 point scale.
Multimodal Care – Brace
Success rate
6 weeks: RR 1.22 (95 % CI 0.9; 1.7)
26 weeks: RR 0.89 (95 % CI 0.5; 1.6)
52 weeks: RR 1.26 (95 % CI 0.5; 3.3)
Difference in Mean Change Score
Severity of Complaints
6 weeks: 5 (95 % CI -2; 12)
52 weeks: -1 (95 % CI -10; 5)
Pain Intensity
6 weeks: 13 (95 % CI 3; 21)
26 weeks: -1 (95 % CI -12; 10)
52 weeks: 0 (95 % CI -10; 11)
PFFQ
6 weeks: 7 (95 % CI 1; 12)
26 weeks: 0 (95 % CI -6; 7)
52 weeks: -3 (95 % CI -9; 3)
There were no clinical or statistical differences between groups in inconvenience during daily activities, pain-free grip strength, maximum grip strength or pressure pain threshold at any follow-up point.
Satisfaction
6 weeks: 9 (95 % CI 1, 18)
Multimodal Care – Combination
Success rate
6 weeks: RR 0.90 (95 % CI 0.6; 1.3)
26 weeks: RR 1.31 (95 % CI 0.7; 2.4)
52 weeks: RR 0.87 (95 % CI 0.3; 2.4)
Difference in Mean Change Score
Severity of Complaints
6 weeks: -6 (95 % CI -12; 1)
52 weeks: -3 (95 % CI -11; 4)
Pain Intensity
6 weeks: 7 (95 % CI -4; 17)
26 weeks: -4 (95 % CI -14; 7)
52 weeks: 2 (95 % CI -8; 13)
PFFQ
6 weeks: -2 (95 % CI -8; 4)
26 weeks: -6 (95 % CI -12; 1)
52 weeks: -5 (95 % CI -12; 1)
There were no clinical or statistical differences between groups in inconvenience during daily activities, pain-free grip strength, maximum grip strength or satisfaction at any follow-up point.
Pressure pain threshold
6 weeks: −13 (95 % CI −25; −1)
Combination--Brace
Success rate
6 weeks: RR 1.11 (95 % CI 0.8; 1.5)
26 weeks: RR 1.17 (95 % CI 0.6; 2.2)
52 weeks: RR 1.10 (95 % CI 0.4; 2.8)
Difference in Mean Change Score
Severity of Complaints
6 weeks: 11 (95 % CI 6; 18)
52 weeks: 1 (95 % CI −6; 8)
Pain Intensity
6 weeks: 6 (95 % CI −15; 4)
26 weeks: 5 (95 % CI −7; 17)
52 weeks: −2 (95 % CI −12; 8)
PFFQ
6 weeks: 9 (95 % CI 2; 15)
26 weeks: 6 (95 % CI −1; 13)
52 weeks: 2 (95 % CI −5; 9)
There were no clinical or statistical differences between groups in inconvenience during daily activities, pain-free grip strength, maximum grip strength or pressure pain threshold at any follow-up point.
Satisfaction
6 weeks: 11 (95 % CI 3; 19)
  1. aCalculated by OPTIMa team [58, 59]
  2. bAdjusted for baseline value of outcome measure and demographic characteristics
  3. c:Adjusted for gender, age, education, BMI, physical activity, physical strain at work, social support at work, pain in shoulder or forearm/hand past 3 months, baseline distress, baseline pain, tennis elbow on dominant side
  4. d:P < 0.05, CI not provided
  5. Acronyms: CI Confidence Interval, CTSAQ Carpal Tunnel Syndrome Assessment Questionnaire, GP general practitioner, GRC Global Rating of Change, OR Odds Ratio, PFFQ Pain Free Function Questionnaire, PRTEE Patient-rated Tennis Elbow Evaluation, PT physiotherapy, RR Relative Risk, RT1 1-choice reaction time, RT2 2-choice reaction time, S1 1-choice speed of movement, S2 2-choice speed of movement, SRT Simple Reaction Time, VAS Visual Analogue Scale, y.o. years old